Glenmark Pharmaceuticals S.A. (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd India (GPL), announces the discovery and initiation of IND enabling studies of a Novel Biological Entity (NBE) lead candidate, GBR 401, an anti-CD19 monoclonal antibody. GBR 401 is developed completely in-house by its Biologics Research Centre located in Switzerland.
The disease areas primarily targeted by GBR-401 are lymphomas and leukaemia's of B-cell origin. Lymphomas are cancers originating from the lymphatic system. Non-Hodgkin's lymphoma (NHL), a type of B cell lymphoma, is the mos common form of blood cancer. Leukaemia is a cancer of the white blood cells. Within the seven major markets comprising of US, Europe top 5 markets and Japan, new cases of NHL and leukaemia's of B cell origin were estimated at 126,000 and 34,000 respectively. In addition the CD19 target holds potential for treatment of inflammatory disorders such as rheumatoid arthritis.
Commenting on this milestone, Glenn Saldanha, CEO & MD, said, “ We are excited to announce GBR 401, which has been developed completely in-house leveraging our biologics antibody know-how. We are confident that the antibody expertise and product development capabilities of he Switzerland Biologics Research Centre will continue to enrich the Glenmark discovery pipeline.”
Dr Michael Buschle, president-Biologics, Glenmark Pharmaceuticals S.A. Switzerland said, “Targeting CD19 is a promising approach to treat B-cell malignancies. Further, GBR 401 has been developed using a technologically advanced platform that greatly enhances the efficacy of the antibody.”
With the addition of GBR 401 to the pipeline, Glenmark will now have four monoclonal antibodies in the NBE pipeline viz., GBR 500, GBR 600 and GBR 900. GBR 401 shows great promise to emerge as a valuable therapeutic option to treat patients affected with B-cell malignancies. GBR 401 has demonstrated strong anti-tumour potency and anti-proliferative apoptotic activity in several in-vitro and in-vivo studies. CD19 is known to be expressed earlier and more broadly in B-cell development than CD20, the latter being the target of the worlds second largest selling anti-cancer biotech product rituximab (Rituxan/MabThera) whose annual 2010 sales were in excess of US$ 6 billion. Glenmark will pursue further development of GBR 401 to accelerate its entry into clinical trials.